ARCALYST® (rilonacept) is a prescription medicine called an interleukin-1 (IL-1) blocker. ARCALYST is used to treat adults and children 12 years of age and older with Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

ARCALYST can affect your immune system. ARCALYST can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death have happened in patients taking ARCALYST. Taking ARCALYST can make you more likely to get infections, including life-threatening serious infections, or may make any infection that you have worse.

ARCALYST® (rilonacept) is a prescription medicine called an interleukin-1 (IL-1) blocker. ARCALYST is used to treat adults and children 12 years and older with Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

ARCALYST can affect your immune system. ARCALYST can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death have happened in patients taking ARCALYST. Taking ARCALYST can make you more likely to get infections, including life-threatening serious infections, or may make any infection that you have worse.

You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection).

After starting ARCALYST, if you get an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have any open sores on your body, call your healthcare provider right away. Treatment with ARCALYST should be stopped if you develop a serious infection.

You should not take medicines that block Tumor Necrosis Factor (TNF) or IL-1 while taking ARCALYST. Taking ARCALYST with any of these medicines may increase your risk of getting a serious infection.

Call your healthcare provider or seek emergency care right away if you get any of the following symptoms of an allergic reaction while taking ARCALYST:

Changes in your blood cholesterol and triglycerides (lipids). Your healthcare provider will check you for this

These are not all the possible side effects of ARCALYST. Tell your healthcare provider about any side effects that bother you or that do not go away. For more information ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The impact of treatment with ARCALYST on active and/or chronic infections and the development of malignancies (cancer) is not known. However, treatment with immunosuppressants, including ARCALYST, may increase the risk of malignancies.

Before starting treatment with ARCALYST, tell your healthcare provider if you

Think you have an infection

Are being treated for an infection

Have signs of an infection, such as fever, cough, or flu-like symptoms

Have any open sores on your body

Have a history of infections that keep coming back

Have asthma. Patients with asthma may have an increased risk of infection

Have diabetes or an immune system problem. People with these conditions have a higher chance for infections

Have tuberculosis (TB), or if you have been in close contact with someone who has had tuberculosis

Have or have had HIV, Hepatitis B, or Hepatitis C

Take other medicines that affect your immune system

Before you begin treatment with ARCALYST, talk with your healthcare provider about your vaccination history. Ask your healthcare provider whether you should receive any vaccinations, including pneumonia vaccine and flu vaccine, before you begin treatment with ARCALYST.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The product information in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.